The invention relates to a pacifier nipple comprising a subdivided elastomeric nipple body including a fastening portion, a neck portion and a head portion wherein a receiving space for substances, e.g. a medicament for oral administration, is provided.
The oral administration of medicaments or similar substances to infants often is difficult since the children refuse to take these substances because of their unpleasant taste. Moreover, as a rule tablets cannot be administered to infants because of the risk of suffocation, and in some instances it may be necessary for the active ingredient of the medicament to be released gradually, with the infants, however, being unable to suck tablets or to chew them.
In DE 3,503,777 A, a medicament dispensing nipple has been proposed in which the interior of the entire nipple body forms a receiving space for a medicament; the nipple body is perforated over approximately half its longitudinal extension, and at its rear side it communicates with a refilling channel via which the respective medicament can be introduced into the nipple body. The refilling channel has an associated detachable closing cap. Nipples of similar principle have, furthermore, been proposed in U.S. Pat. No. 5,078,734 A as well as in WO 91/04 727 A.
One disadvantage is that depending on the position of the head of the child who uses the pacifier provided with the medicament dispensing nipple, the medicament may also remain in the rear or outer region of the nipple body and thus outside the mouth. Accordingly, an embodiment has already been proposed in WO 91/04 727 A in which the medicament is lodged between two layers of the nipple body in the front or head portion thereof. However, this is a nipple which can be used only once, whereas it is sought to be able to use a pacifier comprising a dispenser nipple over a longer period of time, also for a more frequent medicament delivery.
The disadvantage of the incomplete administration of the respective medicament during sucking on the pacifier also applies to the pacifier according to CH 684 160 A. The interior of the nipple body of this pacifier is subdivided by a separating wall, with the respective medicament being received in the interior of the neck portion of the nipple body which is separated from the head or palate portion by the separating wall. To deliver the medicament, numerous small perforations are provided in this neck portion.
Yet above all also here it is a disadvantagexe2x80x94just with all the other known nipples with the possibility of administering a medicamentxe2x80x94that the respective medicament is re-filled from the rear or outer side via the fastening portion of the nipple body in the region of the pacifier shield, if the pacifier is used several times as a medicament dispenser, and this requires attaching removable closing parts, such as plugs or the like. Accordingly, this results in releasable pacifier parts, and the pacifier embodiments altogether are not disassembly-proof, resulting in a substantial risk that the infant will swallow parts of the pacifier after an accidental disassembly or detachment of parts thereof.
Also cleaning of the known nipple bodies in their interior after a medicament has been administered is only possible with the greatest difficulties, and the production of the nipple body of the pacifier according to CH 684 160 A with the closed head or palate portion is also difficult.
As has already been implied before, it has been a wish for some time to design comforters or pacifiers as disassembly-proof and orthodontologically suitable as possible. In this connection mention may be made, e.g., of AT 338 440 B.
The invention thus has as its object to provide a nipple of the above defined type, in which the medicament to be administered need not be introduced from the rear side of the exterior of the pacifier, through the attachment portion of the nipple body, so that this nipple is suitable for use in a disassembly-proof pacifier, such as the one according to the afore-mentioned AT 338 440 B; moreover, the nipple is to be easy to produce and also easy to clean, and filling with a medicament nevertheless shall not pose any problems.
The pacifier nipple according to the invention of the initially defined type is characterized in that the receiving space is provided in the head portion that is separated from the neck portion and that the head portion is provided with a sealing lip abutting on the remaining nipple body and liftable therefrom.
In the pacifier nipple according to the invention thus the respective medicament to be administered or, generally, the substance is received in the front head portion of the nipple body, and thus it is ensured that the child will take in this substance gradually during sucking when using the pacifier. For filling the receiving space in the head portion, the sealing lip thereof may be lifted off the remaining nipple body to the appropriate extent. The administration of the substance to the infant may also be effected by axe2x80x94slighterxe2x80x94lifting of the sealing lip, the extent of lifting being controllable by the intensity of sucking. The present nipple is easy and well to be cleaned if the sealing lip is lifted off the remaining nipple body or is reversed.
Other than the nipple pacifiers according to the prior art, this nipple configuration is also suitable for collecting the saliva of the infant, e.g. for medical tests, in an advantageous manner, since during sucking, by lifting the sealing lip at the xe2x80x9cvalve seatxe2x80x9d formed by the remaining nipple body, saliva may get past the xe2x80x9cvalve seatxe2x80x9d into the interior of the head portion, i.e. into its receiving space, in sufficient amounts. There, it is also advantageous to provide a foam material body in the receiving space which takes up the saliva like a sponge. This foam material body may, e.g., have the shape of a slit ring.
An embodiment has proven particular advantageous in which the head portion comprises a hood connected with the remaining nipple body and adjoining the remaining nipple body at least over part of its periphery via a separating line, the hood being outwardly reversible. The nipple may be produced in a state in which the hood is outwardly reversed so that in that state there are no overlapping parts, which simplifies the production in one piece. The preferred integral configuration of the nipple body not only has the advantage of a simple production, but moreover, also that of being more resistant against an undesired separation which, e.g., might happen if the nipple body is produced in parts which are connected later on, such as by gluing.
Accordingly, it is to be particularly preferred if the hood is integrally connected with the remaining nipple body.
Although it would be possible to connect the hood in one piece with the remaining nipple body via a more or less strip-shaped outer web that forms part of the nipple body jacket, it is particularly suitable with a view to the attainable higher strength as well as, finally, also the simpler mould design and production if, via an axial, central shaft part, the hood is connected with a front-end wall that closes the neck portion. With such a configuration, the hood with its entire free rim which normally faces the remaining nipple body, can be reversed in the direction away from the fastening and neck portions of the nipple body, so that then a reversed xe2x80x9ccupxe2x80x9d is present which is connected in one piece with the remaining nipple body via a central xe2x80x9cstemxe2x80x9d, the shaft part. There, it is furthermore advantageous if the shaft part has at least one opening for the clamping retention of medicaments in the form of tablets or capsules.
The remaining nipple body suitably has a step- or shoulder-shaped abutment surface as xe2x80x9cvalve seatxe2x80x9d at the periphery of the separating wall where the free rim of the hood rests in its normal position. However, to facilitate the delivery of the medicament received in the receiving space, i.e. in the interior of the hood, a passage of appropriately small cross-section may be provided in this abutment or sealing region so as not to cause an undesired, excessive seeping out of the medicament before the pacifier provided with the nipple is used. Accordingly, an advantageous embodiment is characterized in that at least one channel-shaped passage is provided on the rim of the hood adjacent the remaining nipple body and the hood otherwise rests on the remaining nipple body with its rim acting as a sealing lip.
Yet, it is, of course, also possible that at least one passage opening is provided in the hood in a manner known per se for delivery of the medicament.
As known per se, the nipple body may be made of the most varying rubber materials, yet preferably it is made of silicone caoutchouc.
The invention also has as its object an advantageous method of producing a nipple according to the invention, wherein the nipple body is moulded of an injection-mouldable mass, in particular silicone caoutchouc, and this method according to the invention is characterized in that the nipple body is moulded in its state with outwardly reversed hood and that the hood is turned back into its normal position after the nipple body has been removed from the mould. In this manner, as has already been implied before, despite the relatively complicated form of the nipple body in its normal state with the super-imposed regions, a simple production in one step is possible without any problems. In doing so, it may also be provided that during the moulding of the nipple body with its outwardly reversed hood, simultaneously at least one passage opening is formed by aid of at least one spike insert. Moreover, it is suitable if during moulding of the nipple body, simultaneously at least one opening is shaped in the shaft part by aid of at least one spike insert.
Finally, the invention also relates to a device for producing the present nipple according to the method of the invention, with a mould corresponding to the nipple body, wherein, according to the invention, the mould has an associated core for forming the outward-reversed hood. There, moreover, it is advantageous if a further core located opposite the core for the formation of the reversed hood is provided for forming the hollow fastening and neck portions of the nipple body. This further core may, however, be done without if a solid, i.e. full mass configuration of the fastening and neck portion nipple body were desired.
To simultaneously perforate the hood for the passage of the medicament in one operation it is, finally, suitable if the mould has recesses for inserts for the moulding of the passage opening(s) in the hood and/or the opening(s) in the shaft part.